Global longitudinal strain to predict difficult separation from cardiopulmonary bypass
Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass
This will test whether a heart ultrasound measure called global longitudinal strain (GLS) can predict which adults having elective cardiac surgery will have trouble coming off cardiopulmonary bypass.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 213 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital Government |
| Locations | 2 sites (Rome and 1 other locations) |
| Trial ID | NCT07390903 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter observational study will measure GLS by speckle-tracking echocardiography before and after elective cardiac surgery that uses cardiopulmonary bypass. Patients undergoing procedures such as isolated valve surgery, CABG, combined valve+CABG, or ascending aorta operations will have perioperative echocardiograms and routine postoperative monitoring. The study will compare preoperative GLS and perioperative changes with intraoperative difficulty separating from bypass and with outcomes including ICU stay, hospital length of stay, cardiac biomarkers, and 30-day mortality. Exclusions include emergency or redo surgery, active preoperative mechanical support, ongoing inotropes, mechanical ventilation, and preoperative atrial fibrillation.
Who should consider this trial
Good fit: Adults (over 18) scheduled for elective cardiac surgery requiring cardiopulmonary bypass who can give consent and do not have critical preoperative support or atrial fibrillation are ideal candidates.
Not a fit: Patients undergoing emergency or redo operations or those already on mechanical circulatory support, ongoing inotropes, mechanical ventilation, or with preoperative atrial fibrillation are excluded and unlikely to benefit from these GLS-based predictions.
Why it matters
Potential benefit: If successful, GLS could identify patients at higher risk of difficult CPB separation so teams can plan targeted monitoring and support to reduce complications.
How similar studies have performed: GLS has shown prognostic value in multiple cardiac conditions and small perioperative series suggest associations with outcomes, but large, definitive perioperative data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Age \> 18 years. * Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB). * Provided written informed consent to participate. * Eligible surgical procedures include: * Isolated mitral valve replacement or repair. * Isolated aortic valve replacement or repair. * Isolated coronary artery bypass grafting (CABG). * Combined valve and CABG surgery. * Multiple valve replacement or repair. * Surgery involving the ascending aorta or aortic arch. Exclusion Criteria * Emergency cardiac surgery. * Redo cardiac surgery. * Contraindications to transesophageal echocardiography (TEE). * Critical preoperative conditions, including: * Ongoing inotropic drug therapy. * Preoperative mechanical circulatory support (e.g., IABP, ECMO, VAD). * Requirement for mechanical ventilation. * Preoperative atrial fibrillation.
Where this trial is running
Rome and 1 other locations
- University of Rome Tor Vergata — Rome, Italy (Recruiting)
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Mustafa E Gurcu, MD
- Email: emregurcu@gmail.com
- Phone: +905058917800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.